A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Disease
- Sponsor
- Biosensors Europe SA
- Enrollment
- 1707
- Locations
- 10
- Primary Endpoint
- Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.
Detailed Description
Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>= 18 years;
- •Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
- •Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
- •No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion Criteria
- •Pregnancy;
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
- •Inability to provide informed consent;
- •Currently participating in another trial before reaching first endpoint;
- •Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
Outcomes
Primary Outcomes
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time Frame: 9 month
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Secondary Outcomes
- Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.(5 year)
- Cardiac death(5 year)
- In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.(9 month)
- Angiographic and clinical stent thrombosis.(5 years)
- All deaths(5 years)
- In-stent and in-segment binary restenosis rate as assessed by QCA.(9 month)
- In-stent and in-segment late luminal loss(9 month)
- Myocardial infarction(5 years)
- In-segment percent diameter stenosis (%DS).(9 month)
- Device success, lesion success and procedural success.(at implant)